FDA applicant

LivaNova USA, Inc.

Arvada, CO5 decisions1997–202630 recalls

FDA records 5 decisions for LivaNova USA, Inc. (Arvada, CO) from 1997 to 2026: 3 510(k) clearances and 2 original PMA approvals. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and MNQ (Stimulator, Hypoglossal Nerve, Implanted, Apnea). Its devices cite 7 predicates, 0 of them its own earlier devices. 30 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided LivaNova USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007high 2 (2026) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2025

2007high 5 (2018) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — LivaNova USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like LivaNova USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “LivaNova”

FDA records each applicant name separately; these may or may not be the same firm.

Livanova Deutschland, GmbH 7

LivaNova USA, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “LivaNova”